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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72654

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 20, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Spine, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

Z-0454-2016
Recall number
Z-0454-2016
Initiated
November 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
16 devices

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length

Code information

LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Distribution pattern

US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.